Professors Push Sharfstein for FDA Commissioner

Harvard University government professor David Carpenter and Yale School of Public Health assistant professor Gregg Gonsalves are urging President Joe Biden to choose former FDA principal deputy commissioner Joshua Sharfstein as the new FDA commissioner. Writing in a Stat News opinion piece, Carpenter and Gonsalves say they have interacted with Sharfstein on panels but are not friends of his. “He did not ask us to write this essay, and has no idea we are writing it,” they declare.

The authors review Sharfstein’s career at FDA and elsewhere and say he is the right person to help the agency recover from “the political weakness too often shown by commissioner Stephen Hahn. FDA needs a leader experienced in the public health sphere and with management experience at the very top of it. FDA also needs new blood in its leadership.”

In pushing for Sharfstein’s appointment, Carpenter and Gonsalves also take shots at acting commissioner Janet Woodcock, another person they believe to be under consideration for the post. They review her role in approving Sarepta Therapeutics’ Exondys 51 for Duchenne’s muscular dystrophy, overruling staff and an advisory committee, and say the approval has been “silently but massively rebuked by the American healthcare system,” shown especially in the refusal of insurers to pay for it.

The authors also look at Woodcock’s purported role in delaying authorization for the Plan B emergency contraceptive because, she said, access to the drug would lead to extreme promiscuity among adolescents. They say studies have since demonstrated that feared promiscuity has not occurred.

“Woodcock’s service as a civil servant is distinguished, but the post of FDA commissioner calls for a different set of skills, and someone who can withstand the political pressures that face the agency even during ordinary times,” the professors conclude. “As a weary and uncertain America faces the likelihood of needing continual rollout of new coronavirus treatments in the years to come, the stakes for President Biden’s choice for FDA leadership could not be higher. A public health leader with top-level FDA experience, a distinguished service record in state and local government, and a commitment for procedural integrity is available in Dr. Joshua Sharfstein. We hope that the president will make the wise and courageous choice to appoint him as America’s next FDA commissioner.”